Renal and Cardiac Risk Factors of AKI After Liver Transplantation

NCT ID: NCT05666232

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-04-30

Brief Summary

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Background: Liver transplantation (LT) is an extensive operation with various factors contributing to the development of acute kidney injury in the perioperative period. Early diagnosis of AKI can improve clinical outcomes in LT recipients. Renal resistive index is measured in renal arteries and high resistive values are associated with more adverse cardiovascular events and renal failure progression. Myocardial performance index reflects overall cardiac function rather than systolic or diastolic function alone.

Aim of the study: to investigate whether combined doppler renal resistive index and myocardial performance index could predict early postoperative acute kidney injury in living donor liver transplant recipients.

Study design: a prospective observational study that will be conducted at Liver Transplantation Unit at Mansoura University on 105 consecutive living donor liver transplant recipients.

Methods: Renal resistive index (assessed by transabdominal ultrasound) and myocardial performance index (assessed by transthoracic echocardiography) will be measured just before operation, on termination of operation and then daily in the intensive care unit for 7 days. Patients will be observed for development of acute kidney injury.

Detailed Description

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This study aims to investigate whether combined doppler renal resistive index (RRI) assessed by transabdominal sonography and myocardial performance index (MPI) assessed by transthoracic echocardiography could predict early postoperative acute kidney injury in living donor liver transplant recipients.

The primary outcome is the predictive value of renal resistive index and myocardial performance index for the onset of early post living donor liver transplant acute kidney injury.

This prospective observational study will be conducted at Liver Transplantation Unit at Mansoura University from November 2022 till fulfillment of sample size after obtaining approval from Institutional Review Board (IRB). One hundred and five consecutive LDLT recipients will participate in this study after obtaining informed consents. They will be observed for the development of early postoperative acute kidney injury.

Conditions

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Acute Kidney Injury Acute Renal Injury Liver Transplant; Complications

Keywords

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2-D Echocardiography Two-Dimensional Echocardiography renal resistive index myocardial performance index diagnostie test accuracy sensitivity and specificity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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renal resistive index and myocardial performance index

Transthoracic echocardiography and transabdominal ultrasonography will be performed before induction of anesthesia, after termination of operation and before transmission to ICU and then daily for the early seven postoperative days.

RRI = (peak systolic velocity - end diastolic velocity) ∕ peak systolic velocity: Then, we will obtain the mean RRI from the above three measurements.

We will consider RRI ≥0.7 as abnormal and define it as subclinical AKI.

Myocardial performance index (using tissue doppler) =

(isovolumetric contraction time + isovolumetric relaxation time) / ejection time. We will consider MPI ≥0.4 as abnormal and define it as subclinical LV dysfunction.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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echocardiography ultrasonography

Eligibility Criteria

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Inclusion Criteria

* patients undergoing right-lobe living-donor liver transplantation

Exclusion Criteria

* preoperative renal impairment (GFR \< 60 ml/min/1.73 m2)
* known renal artery stenosis
* patient who underwent previous nephrectomy
* ischemic heart disease (patient who takes anti-ischemic measures as prescribed by a consultant cardiologist)
* Patient with arrthymia or who develop persistent intraoperative arrythmia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amr Yassen, MD

Role: STUDY_CHAIR

Mansoura University Hospital

Central Contacts

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Ahmed Ali El-din, MSc

Role: CONTACT

Phone: 1288045390

Email: [email protected]

Moataz M Emara, MD, EDAIC

Role: CONTACT

Phone: 1064048848

Email: [email protected]

Other Identifiers

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MD.22.09.699

Identifier Type: -

Identifier Source: org_study_id